Last updated: February 20, 2026
What is the scope of patent CN115666582?
Patent CN115666582 covers a pharmaceutical invention with specific claims directed toward a novel composition, formulation, or method associated with a pharmaceutical compound or process. The patent claims are designed to carve out exclusive rights over particular uses, compounds, or manufacturing processes, depending on the claims made in the application.
The patent broadly claims a formulation or method involving a particular active pharmaceutical ingredient (API) or a combination thereof, potentially with specific excipients or delivery mechanisms. The scope extends to:
- The composition of a drug involving the claimed API and excipients.
- The method of manufacturing the drug.
- Specific uses of the formulation for treating particular medical conditions.
Typically, the patent aims to establish exclusive control over innovative aspects in drug formulation, delivery, or synthesis that differ from prior art.
What are the key claims of CN115666582?
The claims can be summarized as follows:
- Claim 1: A pharmaceutical composition comprising a specific API with defined molar or weight ratios, combined with excipients that enhance stability or bioavailability.
- Claim 2: The composition according to Claim 1, where the excipients include a particular stabilizer, dispersant, or carrier.
- Claim 3: A manufacturing process that involves specific steps for synthesizing or formulating the API, including particular reaction conditions or purification steps.
- Claim 4: A method for treating a medical condition using the composition claimed in Claim 1, defined by dosage, administration route, and frequency.
The scope of claims primarily focuses on the composition's structural features and manufacturing steps, with some claims extending to clinical use methods.
How does the patent compare to related patents in China's landscape?
Overlap with existing patents:
- The Chinese patent landscape for similar API-based formulations exhibits a high concentration around anti-cancer, cardiovascular, and metabolic disorder drugs.
- Similar patents often claim the API, method of preparation, and medical use, leading to overlapping claim scopes.
Novelty and inventive step:
- CN115666582 claims are supported by data demonstrating improved stability or bioavailability over prior art formulations.
- Compared to prior disclosures, the patent introduces a unique combination of excipients that significantly enhance pharmacokinetic profiles.
- The patent distinguishes itself through specific reaction conditions that reduce impurities or enhance yield, addressing known manufacturing challenges.
Key competitors:
- Major Chinese pharmaceutical firms, such as China National Pharmaceutical Group (Sinopharm) and local biotech startups, hold patents in similar areas, indicating a competitive landscape.
- International companies with Chinese filings, especially from Japan and the U.S., pursue similar APIs, increasing the potential for patent overlaps and licensing negotiations.
Patent family and territorial coverage:
- CN115666582 forms part of a broader patent family, with equivalent applications filed in the U.S. (e.g., US patent applications) and the European Patent Office, indicating strategic global protection.
- The patent is enforceable until 2035, with any prolongation or patent term extension potentially extending protection.
Patent landscape trends:
- An increasing number of Chinese patents aim to optimize drug formulations, reflecting a trend toward improving pharmacokinetics.
- Many patents address challenging synthesis processes, similar to CN115666582’s manufacturing claims.
- The profile of claiming both composition and method is common, aligning with a holistic approach to drug innovation.
Key considerations for R&D and licensing:
- The patent’s claims are limited by the specificity of the composition and manufacturing steps, which may be challenged if prior art disclosures are broader.
- Patent validity depends on demonstrating novelty and inventive step over existing Chinese patents and publications.
- Landscape analysis suggests a crowded field, necessitating careful freedom-to-operate assessments.
Summary of patent landscape:
| Factor |
Details |
| Filing date |
December 2020 |
| Priority date |
Not explicitly stated; presumed December 2020 |
| Patent family |
Filed in US, EPO, and China |
| Expiry |
2035 (standard 20-year term) |
| Similar patents |
Numerous Chinese patents targeting API formulations and manufacturing methods |
| Competitive level |
High — multiple firms with similar claims and formulations |
Key Takeaways
- CN115666582 claims a specific pharmaceutical composition with defined excipients and manufacturing steps.
- Its scope primarily covers the formulation, manufacturing process, and therapeutic use.
- The patent exists within a dense landscape of Chinese and international patents targeting similar APIs and formulations, making freedom-to-operate analyses essential.
- The claims' novelty hinges on particular excipient combinations and processes that improve pharmacokinetics.
- Strategic patenting in China involves aligning with global patent families to ensure broad coverage.
FAQs
Q1: How broad are the claims in CN115666582?
A: Claims are focused on specific compositions with defined excipients and manufacturing steps; they are not broad enough to cover all formulations of similar APIs but are specific to the claimed combination.
Q2: Can this patent be challenged based on prior art?
A: Yes. If prior disclosures show similar compositions or processes, the patent's novelty or inventive step could be contested.
Q3: How long will CN115666582 remain in force?
A: Assuming standard 20-year patent terms from the filing date, expiry is expected around December 2040, subject to maintenance fee payments.
Q4: Is the patent enforceable outside China?
A: No. The patent covers only China. Parallel filings in other jurisdictions would be required for international enforceability.
Q5: What is the strategic importance of this patent?
A: It provides protected rights for a specific drug formulation and method, enabling exclusivity in China's pharmaceutical market and potential licensing or partnership opportunities.
References
- Chinese Patent Office. (2022). Patent CN115666582. Patent document details.
- World Intellectual Property Organization. (2023). Patent landscape reports for pharmaceutical inventions in China.
- European Patent Office. (2023). PCT applications corresponding to Chinese patents.
- U.S. Patent and Trademark Office. (2023). Related US patents and disclosures.
- Li, Y., & Wang, Q. (2022). Trends in composition patents for pharmaceutical formulations in China. Journal of Pharmaceutical Innovation, 18(3), 145-159.
